MAUDE Adverse Event Report: CONVATEC INC ACTIVELIFE 1 PC - 1 PC DRAINABLE POUCH W. DURA; POUCH COLOSTOMY

Model Number 175779

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Event Description

Pt reported that 2 boxes of 5 pouches precut to 25mm product were actually precut to 32 mm size.Same lot number.The end user subsequent outcome was not reported.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issued april 16, 2014.Device(s) listed in this report is (are) used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.It is noted that there are blank areas on this form, the information was not provided or is unk.The returned sample confirmed incorrect product in the market unit.Event (b)(6) has been raised for investigation.

• Brand Name: ACTIVELIFE 1 PC - 1 PC DRAINABLE POUCH W. DURA
• Type of Device: POUCH COLOSTOMY
• Manufacturer (Section D): CONVATEC INC; 211 american ave; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, dir ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4181375
• MDR Text Key: 18259601
• Report Number: 1049092-2014-11751
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K833625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/17/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 175779
• Device Lot Number: 2L01069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/17/2013
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other